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Background: The DAWN antivirals trial was a multicentric, randomised placebo-controlled trial evaluating antiviral medication for COVID-19 in general practice. The trial was prematurely terminated because of insufficient recruitment. Aim: To explore which factors contributed to the premature termination. Design & setting: General practice in Belgium. Method: Patients were randomised to camostat or placebo (patients and physicians blinded) between June 2021 and July 2022; a third arm evaluating molnupiravir (open label) was opened in March 2022. The outcome assessor was blinded for all comparisons except for the patient reported outcomes in case of molnupiravir. The authors analysed available trial data and evaluated trial context, implementation, and mechanisms of impact based on semi-structured interviews with trial stakeholders. Results: The trial recruited 44 participants; 19 were allocated to camostat (median age 55 years), 8 to molnupiravir (median age 60 years), and 17 to placebo (median age 56 years). There were no serious adverse events in either group. Most difficulties were related to the pandemic context: disruption to routine clinical services; multiple changes to the service model for COVID-19 patients; overwhelmed clinical staff; delays of trial medication; and staff shortages in the sponsor and clinical team. In addition, regulatory approval processes were lengthy and led to additional study procedures. It was felt that the trial started too late, when vaccinations had already begun. Conclusion: The DAWN antivirals trial was stopped prematurely. Although many barriers were related to the pandemic itself, hurdles such as a small and inexperienced sponsor and clinical teams, delays in regulatory processes, and research capacity in routine settings could be overcome by established research infrastructure and standardisation of processes. [ABSTRACT FROM AUTHOR]

Paretic side collisions frequently occur in stroke patients, especially while walking through narrow spaces. We determined whether training for walking through an opening (T-WTO) while entering from the paretic side would improve collision avoidance behavior and prevent falls after 6 months. Thirty-eight adults with moderate-to-mild hemiparetic gait after stroke who were hospitalized in a rehabilitation setting were randomly allocated to the T-WTO (n = 20) or regular rehabilitation (R-Control; n = 18) program. Both groups received five sessions of 40 min per week, for three weeks total. T-WTO included walking through openings of various widths while rotating with the paretic side in front, and R-Control involved normal walking without body rotation. Obstacle avoidance ability, 10-m walking test, timed Up and Go test, Berg Balance Scale, Activities-specific Balance Confidence, the perceptual judgment of passability, and fall incidence were assessed. Collision rate and time to passage of the opening in obstacle avoidance task significantly improved in the T-WTO group compared with those in the R-Control group. Contrast, T-WTO did not lead to significant improvements in other outcomes. T-WTO improved efficiency and safety in managing subacute stroke patients. Such training could improve patient outcomes/safety because of the paretic body side during walking. R000038375 UMIN000033926 Individuals with stroke often collide with the paretic side while walking through narrow spaces. Training for walking through a narrow opening from the paretic side improved an individual's ability to avoid obstacles in similar tasks. Moreover, such training could improve patient outcomes/safety because such interventions may temporarily increase attentional focus to the paretic side in specific tasks. [ABSTRACT FROM AUTHOR]

The aim of this study protocol is to examine the effect of telephone‐assisted smoking cessation programme based on the information motivation behavioural skills model on the self‐efficacy, smoking behaviour, tumour recurrence and progression in patients diagnosed with non‐muscle‐invasive bladder cancer. A single‐center, single‐blind, parallel‐group, randomized control trial. The intervention group will receive telephone‐assisted smoking cessation programme, while no intervention will be applied to the control group. Face‐to‐face smoking cessation training will be provided for the information component of the programme, motivational interview will be conducted via WhatsApp for its motivation component. Motivational interviews will be undertaken in total of six sessions organized at two‐week intervals. The patients' chronic disease management self‐efficacy, smoking behaviour will be evaluated at the third, sixth, 12th months. Tumour recurrence, progression will be followed up by cystoscopy at the third, 12th months. This is a randomized controlled study protocol, results are not available at the time of the submission. All results will be reported on the completion of this study. This study protocol, will involve the implementation of comprehensive smoking cessation programme that is much needed for the target population around the world. It is expected that the use of this programme will increase the self‐efficacy of smokers with bladder cancer, decrease their smoking behaviour and amount of smoking, eliminate tumour recurrence. Smoking is the most important, modifiable risk factor for bladder cancer. In this study, it is expected that the implementation of telephone‐assisted smoking cessation programme based on the information–motivation–behavioural skills model will increase self‐efficacy in cancer management and decrease smoking behaviour, tumour recurrence in patients diagnosed with bladder cancer. In the literature, there is no smoking cessation programme based on this model intended for patients diagnosed with bladder cancer. [ABSTRACT FROM AUTHOR]

Background: Although previous studies have showed that epidural morphine can be used as a complement to local anesthetics for analgesia after postcesarean delivery under spinal anesthesia, there is little known about the analgesic dosage of epidural morphine and hydromorphone for hemorrhoidectomy. Therefore, we conducted this study to examine the potency ratio of hydromorphone to epidural morphine as well as effective analgesic dose for 50% patients (ED50) undergoing elective hemorrhoidectomy. Methods: 80 patients under elective hemorrhoidectomy with combined spinal and epidural anesthesia(CSEA) in department of anesthesia, Dongguan Tungwah hospital. To assess the ED50, patients were treated with epidural morphine or epidural hydromorphone randomly using a biased coin method-determined dose with a sequential allocation procedure. Following surgery, standardized multimodal analgesia was administered to all patients. A pain response score of ≤ 3 (on a scale of 0–10) was determined to be the effective dose after 24 h following CSEA. The ED50 in both groups were determined using the probit regression and isotonic regression method. We also measured pain intensity by patient interview using a 10 point verbal numeric rating scale prospectively at 6, 12 and 24 h after CSEA, and adverse effects were also noted. Results: The ED50 was 0.350 mg (95% CI, 0.259–0.376 mg) in hydromorphone group and 1.129 mg (95% CI, 0.903–1.187 mg) in morphine group, respectively, estimated by isotonic regression method. Regression analysis with the probit, the ED50 of epidural hydromorphone was 0.366 mg (95% CI, 0.276–0.388 mg) and epidural morphine was 1.138 mg (95% CI, 0.910–1.201 mg). Exploratory findings showed that there was no difference between the most frequent dosages of epidural hydromorphone or epidural morphine in the occurrence of nausea, vomiting and pruritus. When administered with epidural opioids at ED50 doses or higher, 97.5% (39/40) of epidural morphine patients and 97.5% (39/40) epidural hydromorphone of patients were satisfied with their analgesia. Conclusion: Effective hemorrhoidectomy analgesia requires a 3:1 ratio of epidural morphine to epidural hydromorphone. Both drugs provide excellent patient satisfaction. [ABSTRACT FROM AUTHOR]

Background: Studies assessing the effects of parenting programs have focused on interventions delivered through face-to-face modalities. There is a need for research to evaluate the effects of online parenting programs on child development, such as the BEM Program ('Play Teaches Change' in English), an online play-based parenting program that teaches caregivers on how to introduce playful interactions into their daily household chores. Objective: To assess the effects of the BEM Program on child development and the quality of caregiver-child interaction. Method: A two-arm randomized controlled trial was conducted in a socioeconomically disadvantaged district of São Paulo city in Brazil. 129 children aged 12–23 months and their caregiver were randomly assigned to receive either the BEM Program for 8 weeks (intervention, n = 66) or standard child care (control, n = 63). Data were collected at baseline and endline of the intervention through home visits and online interviews. An intention-to-treat analysis was conducted. Results: The intervention showed positive effects on child development, by improving language development (Cohen's d = 0.20, 95%CI 0.08–0.47) and reduced intrusiveness (Cohen's d = 0.35, 95%CI 0.06–0.65) of caregiver-child interaction. No significant differences were observed in caregiver's repertoire and engagement in age-appropriate play activities with the child while doing the household chores, parenting sense of competence and perceived stress. Conclusions: Despite the small size and low adherence to the program, such promising results advance evidences for fully remote parenting programs and their effects on child development. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to investigate the effectiveness of solution-focused group counseling (SFGC) to reduce depressive symptoms and improve cognitive functions among Chinese rural older adults. Method: In a cluster randomized controlled trial, 290 participants were randomly assigned to a 12-session SFGC intervention or a control group. the Center for Epidemiological Studies Depression Scale and Mini-Mental State Examination was adopted to measure depressive symptoms and cognitive functions, respectively, at pretest and posttest. Results: Repeated measure ANOVAs showed a significant group by time effect for both measures. Paired sample t-tests showed that depressive symptoms significantly decreased in the intervention group, but not in the control group. Cognitive functions did not change in the intervention group, but significantly declined in the control group. Conclusions: Our findings support the feasibility and effectiveness of a culturally adapted SFGC for reducing depressive symptoms and protecting cognitive functions among the disadvantaged older adults in a developing country. [ABSTRACT FROM AUTHOR]

Background: Observational studies have consistently found a link between low serum 25‐hydroxyvitamin D concentration and higher risk of cognitive impairment. Results from randomized controlled trials have been mixed, and few have been conducted in the general population. Methods: We recruited 21,315 community‐dwelling Australians aged between 60 and 84 years to participate in the D‐Health Trial, a randomized, double‐blind, placebo‐controlled trial. The intervention was monthly oral doses of 60,000 international units of vitamin D or placebo for 5 years. We assessed cognitive function in a randomly sampled group of participants aged ≥70 years using the Telephone Interview for Cognitive Status (TICS) at 2 and 5 years after randomization. The primary outcome for this analysis was TICS score; the secondary outcome was the proportion of people who had cognitive impairment (defined as TICS score ≤25). We analyzed data using mixed models (linear and logistic). Results: We interviewed 3887 participants at year 2 and 3614 participants at year 5. The mean TICS score at these time points was 32.3 and 32.2, respectively. Vitamin D supplementation did not affect cognitive function as measured by TICS score (mean difference between vitamin D and placebo groups 0.04; 95% CI −0.14 to 0.23), or alter risk of cognitive impairment (odds ratio 1.00; 95% CI 0.75 to 1.33). Conclusions: Monthly bolus doses of vitamin D supplementation neither enhanced nor hindered cognitive function among older adults. Population‐wide vitamin D supplementation of older adults that are largely vitamin D replete is unlikely to substantially benefit cognition. [ABSTRACT FROM AUTHOR]

Background: Many individuals with posttraumatic stress disorder (PTSD) have limited access to first-line treatments, warranting the development of remotely-delivered treatments. Attention bias modification (ABM), targeting perturbed threat-related attentional patterns, shows promise when delivered in-person. However, previous studies found ABM to be ineffective when delivered remotely. Randomized clinical trials usually applied two variations of ABM: ABM away from threat or attention control training (ACT) balancing attention between threat-related and neutral stimuli. We tested remotely-delivered ACT/ABM with tighter supervision and video-based interactions that resemble in-clinic protocols. We expected to replicate the results of in-clinic trials, in which ACT outperformed ABM for PTSD. Methods: In this double-blinded, parallel-group randomized controlled trial, 60 patients diagnosed with PTSD were randomized (ABM n = 30; ACT n = 30). Patients performed eight bi-weekly remotely-delivered supervised ABM/ACT sessions. Symptoms were assessed pre- and post-treatment with Clinician-Administered PTSD Scale 5 (CAPS-5) severity score and PTSD diagnosis as the primary outcomes. Current depressive episode, current anxiety-related comorbidity, and time elapsed since the trauma were examined as potential moderators of treatment outcome. Results: Significant decrease in CAPS-5 severity scores and PTSD diagnosis was observed following both ACT and ABM with no between-group difference. Patients without depression or whose trauma occurred more recently had greater symptom reduction in the ACT than the ABM group. Conclusions: Contrary to our expectation, symptoms decreased similarly following ACT and ABM. Moderator analyses suggest advantage for ACT in non-depressed patients and patients whose trauma occurred more recently. Further refinements in remotely-delivered ABM/ACT may be needed. [ABSTRACT FROM AUTHOR]

Purpose Pain and stress-related ill-health are major causes of long-term disability and sick leave. This study evaluated the effects of a brief psychosocial program, which previously has been tested for an at-risk population of employees. Methods The Effective Communication within the Organization (ECO) program, where supervisors and employees were trained in communication and problem solving, was compared to an active control consisting of psychoeducative lectures (PE) about pain and stress in a cluster randomized controlled trial. First-line supervisors were randomized to ECO or PE, and a total of 191 mainly female employees with self-reported pain and/or stress-related ill-health were included. The hybrid format programs consisted of 2–3 group sessions. Sick leave data was collected from social insurance registers, before and 6-months after the program. Secondary outcomes (work ability, work limitations, pain-disability risk, exhaustion symptoms, perceived stress, perceived health, quality of life, perceived communication and support from supervisors) were assessed at baseline, post intervention, and at 6-months follow-up. Results No effects were observed on primary or secondary outcome variables. Pain symptoms were common (89%), however a lower proportion (30%) were identified as at risk for long-term pain disability, which might explain the lack of evident effects. The Covid-19 pandemic affected participation rates and delivery of intervention. Conclusion In this study, preventive effects of the ECO program were not supported. Altogether, the findings point at the importance of selecting participants for prevention based on screening of psychosocial risk. Further research on workplace communication and support, and impact on employee health is warranted. [ABSTRACT FROM AUTHOR]

Purpose: We tested the feasibility of survivorship care plan (SCP) delivery with/without a lay health educator (LHE) telephone‐delivered information session among rural cancer survivors, and their effects on health‐related self‐efficacy and knowledge of cancer history. Methods: Randomized trial of cancer survivors from 3 rural oncology clinics featuring either SCP alone (control) or SCP plus LHE‐delivered information session (intervention). Participants completed a questionnaire on health‐related self‐efficacy and knowledge of cancer‐specific medical history. Responses were compared to medical records for accuracy. SCPs were then mailed to participants. Approximately 5 months later, participants completed a follow‐up questionnaire. A subset of participants took part in subsequent qualitative interviews about their study experience. Findings: Of 301 survivors approached, 72 (23.9%) were randomized (mean age 66.4 years; 3.1 years from diagnosis; 62.5% female), and 65 (90.3%) completed the study. Global mental and physical health or self‐efficacy scores did not change significantly from baseline to follow‐up for either group. In exploratory analyses, self‐efficacy increased in participants with inadequate/marginal health literacy in the intervention arm (+0.7, 95% CI = 0.1‐1.2; P =.01). Accuracy of knowledge did not improve but was high at baseline (mean 76.0±14.5%). 60.1% and 48.4% of control and intervention participants, respectively, found SCPs definitely/somewhat useful. Qualitative data (n = 20) suggested that SCPs were helpful to patients when primary and oncology care were less integrated. Conclusions: An LHE‐delivered informational session was feasible but had limited benefit to rural cancer survivors versus delivery of SCP alone but may be of benefit to patients with low health literacy or with less integrated care. [ABSTRACT FROM AUTHOR]

To compare the effects of Kinesio taping® (KT) and external electrical stimulation (ES) in addition to pelvic floor muscle exercise (PFME) and sole PFME in women with overactive bladder (OAB). Patients with OAB were randomly allocated into PFME, PFME + KT, PFME + ES groups. All treatments were carried out for 6 weeks. OAB symptoms with voiding diary and Overactive Bladder-Version8 (OAB-V8), pelvic floor muscle strength (PFMS) with perineometer, quality of life with King's Health Questionnaire (KHQ) were assessed before (BT) and after treatment (AT). AT, the perception of improvement was inquired. AT, OAB symptoms and KHQ scores decreased and PFMS improved in all groups (p < 0.05). The intergroup comparisons revealed a further decrease in voids/day, voids/night, OAB-V8, and some KHQ scores, and a further increase in the perception of improvement in the PFME + KT and PFME + ES groups compared to the PFME group (p < 0.05). In the PFME + ES group, there was a further decrease in numbers of incontinence compared to the PFME group, and in severity measures scores compared to the other groups (p < 0.05). KT and external ES in addition to PFME were more effective than PFME alone in the treatment of OAB. Pelvic floor muscle exercise was found to be effective in reducing overactive bladder symptoms and increasing quality of life. Kinesio taping or external electrical stimulation in addition to pelvic floor muscle exercise is more effective in improving overactive bladder symptoms, quality of life, and perception of improvement than pelvic floor muscle exercise alone. Kinesio taping and external electrical stimulation can be used as a complementary application in the treatment of overactive bladder. Pelvic floor muscle exercise, pelvic floor muscle exercise + Kinesio taping, and pelvic floor muscle exercise + electrical stimulation applications should be included in conservative treatment options in patients with overactive bladder to reduce symptoms and cost, and improve quality of life. [ABSTRACT FROM AUTHOR]

Background: Evaluation of a complex intervention are often described as being diminished by difficulties regarding acceptability, compliance, delivery of the intervention, recruitment and retention. Research of peer learning for nursing students have found several positive benefits while studies of peer learning for newly graduated nurses are lacking. This study aimed (1) to investigate the study process in terms of (a) first-line managers' perspectives on the intervention study, the difficulties they face and how they handle these and (b) new graduates' fidelity to the intervention and (2) to examine the effect of the peer learning intervention in workplace introduction for newly graduated nurses. Methods: A mixed-methods approach using semi-structured interviews with eight managers, repeated checklist for fidelity and questionnaires conducted with 35 new graduates from June 2015 and January 2018, whereof 21 in the intervention group. The peer learning intervention's central elements included pairs of new graduates starting their workplace introduction at the same time, working the same shift and sharing responsibility for a group of patients for 3 weeks. The intervention also included 3 months of regular peer reflection. Results: Managers offered mostly positive descriptions of using peer learning during workplace introduction. The intervention fidelity was generally good. Because of recruitment problems and thereby small sample size, it was difficult to draw conclusions about peer learning effects and, thus, the study hypothesis could either be accepted or rejected. Thereby, the study should be regarded as a pilot. Conclusions: The present study found positive experiences of, from managers, and fidelity to the peer learning intervention; regarding the experimental design, there were lessons learned. Trial registration: Before starting data collection, a trial registration was registered at (Trial ID ISRCTN14737280). [ABSTRACT FROM AUTHOR]

Children with frequent acute respiratory infections are likely to have tonsil enlargement, adversely affecting health and development. This randomized controlled trial study was conducted to determine the effects of acute respiratory infection prevention programs on self-care agency and specific health outcomes measured by frequent respiratory infections and tonsil enlargement among children aged 10-12 years old with tonsil enlargement. Sixty-two children were randomly selected from three schools within 50 districts of the Bangkok Metropolis and then randomly assigned to either experiment (n = 31) or control group (n = 31). The experimental group received the acute respiratory infection prevention program and routine care, whereas the control group received only routine care. The instruments used to collect the data were the demographic information interview, the self-care agency interview for children with tonsil enlargement, the number of respiratory infections in the last three months data interview, and the tonsil grading system. Data were analyzed using descriptive statistics, parametric and nonparametric statistics with related samples and two independent sample t-test. Results revealed that the experimental group had significantly higher self-care agency, fewer respiratory infections during the last three months, and significantly smaller tonsil enlargement than the control group. Moreover, the experimental group had significantly higher self-care agency, fewer respiratory infections during the previous three months, and significantly smaller tonsil enlargement than before receiving the interventions. The findings suggested that this program helps improve self-care agency and specific health outcomes in children with tonsil enlargement. The findings of this study provide evidence for promoting the school nurses and teachers and for further research to validate the results before implementing the practice. [ABSTRACT FROM AUTHOR]

Objectives: The Bipolar at Risk Trial (BART) was a feasibility randomized controlled trial investigating cognitive behavioral therapy (CBT) compared with treatment as usual (TAU) in young people at high risk of developing bipolar disorder (BD). This qualitative study aimed to investigate participants' experiences of trial involvement, and the acceptability of CBT for this population. Design: Participants were those identified as being at risk of bipolar disorder, determined by current symptoms or family history. A purposive sample of twenty‐one participants from both the intervention and TAU arms of the trial was recruited. Methods: Twenty‐one semi‐structured interviews were conducted by service user researchers (13 participants had received therapy and 8 TAU). Interviews were audio recorded with consent from participants and transcribed verbatim. NVivo 11 Pro software was used to conduct an inductive thematic analysis. Results: Super‐ordinate themes were "adaptability and flexibility," "feeling understood and valued," and "relevance of study and intervention" which had two sub‐themes—"value of the trial therapy" and "acceptability of trial processes." Participating in the trial and having therapy enabled participants to feel understood and valued by research assistants (RAs) and therapists. Participants viewed therapy as relevant to their current concerns and valued adaptability and flexibility of RAs and therapists. Conclusions: Findings highlight the importance and value of flexibility, adaptability, and understanding in relationships between participants and trial staff. Findings also indicate that the trial processes and CBT focusing on mood swings are acceptable and relevant to participants from this at risk population. Practitioner points: Young people at risk of bipolar disorder value a flexible approach to assessments and therapy, developing a rapport with research assistants and therapists and opening up to them when they feel comfortable to do so.CBT focusing on coping with mood swings was acceptable to the majority of participants who received it and it was perceived as helpful in ways that were personal to each participant. [ABSTRACT FROM AUTHOR]

Background: Advance care planning (ACP) is intended to help patients and their spokespersons prepare for end-of-life decision making, yet little is known about what factors influence the extent to which spokespersons feel prepared for that role. Objective: To examine spokespersons' perceived preparedness for surrogate decision making after engaging in ACP. Design: Mixed methods experimental design with qualitative thematic analysis and data transformation (creating categorical data from rich qualitative data) of interviews collected during a randomized controlled trial (2012–2017). Setting/Participants: Two tertiary care medical centers (Hershey, PA and Boston, MA). Of 285 dyads (patients with advanced illness and their spokespersons) enrolled in the trial, 200 spokesperson interviews were purposively sampled and 198 included in the analyses. Main Outcomes and Measures: Interviews with spokespersons (four weeks post-intervention) explored spokespersons' perceived preparedness for surrogate decision making, occurrence of ACP conversations, and spokespersons' intentions regarding future surrogate decisions. Data transformation was used to categorize participants' responses into three categories: Very Prepared, Very Unprepared, or In Between Prepared and Unprepared. Themes and categories were compared across arms. Results: About 72.72% of spokespersons (144/198) reported being Very Prepared and 27.28% (54/198) reported being Very Unprepared or In Between with no differences in preparedness across study arms. Occurrence of post-intervention ACP conversations did not influence perceived preparedness; however, spokespersons who used an ACP decision aid reported more conversations. Four themes emerged to explain spokespersons' perceived preparedness: (1) perceptions about ACP; (2) level of comfort with uncertainty; (3) relational issues; and (4) personal characteristics. Regarding future intentions, it emerged that spokespersons believed their knowledge of patient wishes, as well as other personal, relational, situational, and emotional factors would influence their surrogate decisions. Conclusions: Factors extrinsic to specific ACP interventions influence how prepared spokespersons feel to act as spokespersons. Understanding these factors is important for understanding how to improve concordance between patients' stated end-of-life wishes and surrogate decisions. Trial Registration: NCT02429479 [ABSTRACT FROM AUTHOR]

Aims: Medical procedures and hospitalizations can be experienced as traumatic and can lead to post-traumatic stress reactions. Eye movement desensitization and reprocessing (EMDR) shows promising results but very few long-term studies have been published. Therefore, our aim was to test the long-term (8 months post-treatment) effectiveness of EMDR in children and adolescents with medically related subthreshold post-traumatic stress disorder (PTSD). Methods and results: Seventy-four children (including 39 with congenital or acquired heart disease) aged 4–15 (M = 9.6 years) with subthreshold PTSD after previous hospitalization were included into a parallel group randomized controlled trial. Participants were randomized to EMDR (n = 37) or care-as-usual (CAU) (n = 37; medical care only). The primary outcome was PTSD symptoms of the child. Secondary outcomes were symptoms of depression and blood–injection–injury (BII) phobia, sleep problems, and health-related quality of life (HrQoL) of the child. Assessments of all outcomes were planned at baseline and 8 weeks and 8 months after the start of EMDR/CAU. We hypothesized that the EMDR group would show significantly more improvements on all outcomes over time. Both groups showed improvements over time on child's symptoms of PTSD (only parent report), depression, BII phobia, sleep problems, and most HrQoL subscales. GEE analyses showed no significant differences between the EMDR group (nT2 = 33, nT3 = 30) and the CAU group (nT2 = 35, nT3 = 32) on the primary outcome. One superior effect of EMDR over time was found for reducing parent-reported BII phobia of the child. Conclusion: EMDR did not perform better than CAU in reducing subthreshold PTSD up to 8 months post-treatment in previously hospitalized children. Possible explanations and clinical implications are discussed. [ABSTRACT FROM AUTHOR]

Objective: Assess the feasibility and acceptability of an Internet and telephone support and problem-solving intervention for stroke caregivers. Design: Randomized controlled pilot trial with four arms: four-week intervention (n = 13), eight-week intervention (n = 13), eight-week attention control (n = 13), and standard care (n = 14). Setting: Southeastern U.S. Veterans Health System. Participants: Informal caregivers of Veterans who suffered a stroke in the preceding 2.5 years were enrolled over an 18-month period. Interventions: Intervention participants received RESCUE, a support and problem-solving intervention delivered via telephone and Internet by registered nurses. Attention control participants received active listening with no advice delivered by nurses via telephone. Main Measures: Feasibility of a larger trial was assessed via recruitment and retention. Acceptability was assessed using an adapted enactment tool and qualitative interviews. Changes in caregiver depressive symptoms and burden were measured by the Center for Epidemiologic Studies Depression Scale and Zarit Burden Interview. The study was not powered for significance testing. Results: Of 340 eligible caregivers, 53 (16%) agreed to participate. Among those enrolled, 51 (96%) completed the study. Caregiver mean age was 60.3 (10.1), 49 (93%) were female and 36 (68%) were white. At baseline, 21 (39%) caregivers had high risk of depression and 18 (33%) had significant burden. Acceptability and enactment tool findings indicated positive participant responses to the intervention. Most rated the amount of sessions the "right amount". Qualitative analysis revealed the intervention was valued by and acceptable to caregivers. Conclusions: Findings indicate the RESCUE intervention is feasible and acceptable to caregivers and warrants further testing. [ABSTRACT FROM AUTHOR]

Background and aim: Reducing alcohol misuse by male prisoners is an important global issue. Control of drinking behaviour could be a useful target for intervention in this population, and locus of control could be a causal factor in this. We aimed to assess the effect of a clinical psychologist‐facilitated group intervention on male prisoners' locus of control of drinking behaviour. Design A two‐arm, single‐site, open, randomized controlled trial. Setting: A category B local training prison in South Wales, housing about 770 mainly sentenced men. Participants: Prisoners serving less than 2 years who met inclusion criteria for pre‐imprisonment alcohol misuse, alone or with drug misuse. A total of 119 were allocated to the intervention arm and 119 to the control arm; 104 and 87, respectively, completed the post‐randomization baseline interview and 68 and 60 completed a second interview approximately 4 weeks later, respectively, after intervention or treatment as usual (TAU) alone. Intervention: Nine clinical psychologist‐facilitated groups in the prison over 3 weeks. Range of participants per session was one to seven, with three to five most usual. Measures: The primary outcome was locus of control of behaviour (LCB); secondary outcomes included mental state generally (comprehensive psychiatric rating scale/CPRS) and specifically (Beck Depression Inventory/BDI). An integral process evaluation was conducted. Findings LCB scores decreased during the study, but without significant intervention effect [−1.7, 95% confidence interval (CI) = –5.1 to 1.6, P = 0.329]. Change among completers in the control group was from a mean score of 37.4 [standard deviation (SD) = 10.0] to 33.7[SD = 11.7] and in the intervention group from 37.4 (SD = 11.6) to 31.9 (SD = 11.8). Secondary outcomes, including change in mental state, did not differ between arms, but 686 (64%) sessions were lost, most because of 'prison issues'. Conclusions: A clinical psychologist‐facilitated group intervention did not have a statistically significant effect on sense of control of drinking behaviour among men with pre‐imprisonment alcohol misuse serving less than 2 years in a South Wales prison. The study proved coterminous, however, with 40% prison staff cuts which seem likely to have contributed to the high loss of group sessions and possibly overwhelmed any treatment effect. Intervention completion failures, previously cited as harmful, had no effect here, so the trial should be repeated when the prison climate improves. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effectiveness of education using avatars for improving patients' heart failure knowledge and self‐care. Background: A lack of knowledge and self‐care contributes to poor outcomes and rehospitalization for people with heart failure. Design: A multi‐centred, non‐blinded pragmatic randomized controlled trial. Methods: Heart failure patients were randomly assigned to intervention (avatar education application) or usual care groups. Participants were followed up at baseline, 30 and 90 days. ANCOVA was used to compare the scores of heart failure knowledge and self‐care, between the two groups. Fisher's exact test was used to compare the two groups' heart failure‐cause readmission. Bivariate exact binary logistic regression was used to identify the predictors associated with baseline levels of knowledge. Results: A total of 36 participants were recruited (between October 2018 ‐ March 2019). The mean age of participants was 67.5 (SD 11.3) years. At enrolment, approximately half (47.2%) have been living with Heart Failure for over 5 years. Two groups were comparable at baseline in their demographic and clinical characteristics. At 90 days, the intervention group participants had a higher increase in knowledge score on the Dutch Heart Failure Knowledge Scales compared with the control group (22.2% versus 3.7% P =.002, partial η2 = 0.262, 95% CI −2.755 to −0.686). There was no between‐group difference observed at 30‐ or 90‐day follow‐up, on self‐care behaviour (Self‐care of heart failure index) or healthcare use. Overall satisfaction with the avatar app was 91.3%. Conclusion: The addition of a co‐designed avatar app to usual care improved knowledge in our group of Heart Failure participants at 30 days and continued to increase up to 90 days. The results suggest that our avatar app was perceived as an enjoyable and engaging means of delivering critical knowledge and self‐care information. Impact: Heart failure is associated with poor clinical outcomes (i.e., readmission rates and mortality rate) and substantial economic burden. The effectiveness of Heart Failure patient education using avatar have not been investigated previously. In this study, the avatar app improved knowledge and self‐care behaviours. This innovation could be used at the bedside, at home by nurses, patients and families. Trial Registration: Australian New Zealand Trial Registry ACTRN12617001403325. [ABSTRACT FROM AUTHOR]

Background: Effective recruitment of patients by health professionals is challenging but pivotal to the success of clinical trials. Many trials fail to include the required number of participants, which affects the power of the study, generalizability of results, and timely dissemination of positive outcomes. Existing research is inconclusive regarding factors influencing recruitment results, and most research does not focus on perceptions of recruiting health professionals themselves. Therefore, thorough evaluations of recruitment facilitators and barriers in trials are needed in order to optimize future patient recruitment in trials. We observed divergent recruitment results among nurses who recruited diabetes patients to our trial, which examined the effectiveness of an eHealth programme. Therefore, we aimed to describe nurses' recruitment results and related shifts over time, and to qualitatively explore factors influencing nurses' recruitment results. Methods: Nurses' recruitment results and related temporal shifts were derived from trial data (NTR6840). Based on their recruitment results, nurses were categorized as non-, low-, medium-, or high-recruiters. Subsequently, a subset of nurses per group participated in an individual semi-structured telephone interview. Interviews were analysed using NVivo software, applying an inductive coding approach. Results: Ninety-six nurses participated in our trial and recruited on average seven patients (range: 0–32). Fifteen nurses did not recruit any patients. Most patients were recruited close to recruitment onset. Nurses who did not recruit patients close to recruitment onset generally ended up recruiting no patients. Data show a relatively high number of early recruited patients that progressively declined over time. High-recruiters were generally successful throughout the entire recruitment period. Recruitment facilitators and barriers comprised organizational, study, patient, and especially recruiter characteristics. Contrary to non- and low-recruiters, medium- and high-recruiters reported more in-depth knowledge about the study and trial requirements, expressed more personal participation-related benefits and fewer barriers, and incorporated more recruitment activities, reminders, and barrier-focused coping strategies. Conclusion and implications: To optimize patient recruitment to clinical trials, suggested intervention targets include the continued inclusion of recruiters after initial recruitment onset and the encouragement of early recruitment success. A personalized approach may aid recruiters to become and remain successful. Primarily, it is important to provide recruiters with sufficient information on trial requirements and to address salient benefits for participation in the trial, both for themselves and for their patients. Finally, teaching recruiters skills on how to overcome barriers may further enhance motivation and recruitment capacities. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. Design: Randomized controlled trial. Setting: State welfare organization in Kamyaran, Kurdistan, Iran. Participants: Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. Interventions: Participants in the ACT group (n = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group (n = 29) received psychoeducation regarding depression. Main measures: Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. Results: After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT –10.39 ± 0.79 vs control 0.66 ± 0.68, P < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control –0.03 ± 0.51, P < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control –1.90 ± 1.04, P < 0.001). Conclusion: Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this paper is to describe and discuss both the early implementation of a US mental health intervention for young children in the context of its introduction to a pilot site in a London borough and the progress made in establishing a randomised controlled trial (RCT). Design/methodology/approach: This paper describes an evaluation of a new intervention and the learning that followed in terms of its implementation and future evaluation. Qualitative data were collected from a range of stakeholders and practitioners through interviews and small group discussions. These interviews focussed on both of these issues, with particular reference to the proposal to conduct an RCT. Findings: The findings of this evaluation add to the evidence on how best to support new initiatives that have been introduced from other settings and countries to embed in a receiving site and the optimal timing and feasibility of conducting an RCT. At the end of the feasibility study, which took place within the year of the service being introduced and which was only open to clients for six months of this year the conclusion was that an RCT at that point was neither possible nor desirable. Over the following years, the commitment of the judiciary to examine if there was a way to make an RCT study in respect of this intervention meant that a template was established that may well have broader application. Research limitations/implications: At a time when there is an increasing demand for evidence on effective interventions this paper makes a valuable contribution to the development of RCTs in general and specifically in the family court arena. It also recommends that attention must also be paid to the time, which is needed to implement and establish interventions and then to test them. Practical implications: This paper highlights the need to establish realistic timescales not only around the implementation of initiatives but also for their evaluation. Originality/value: This study breaks new ground in considering implementation challenges in the court and children's services' context. It brings to the fore the important role of the judiciary in approving new processes. [ABSTRACT FROM AUTHOR]

Objective: The objective of this study was to compare the relative effectiveness of dialectical behavior therapy guided self‐help (DBT‐GSH) and DBT unguided self‐help (DBT‐USH) with an unguided self‐help control condition in the treatment of binge‐eating disorder (BED). Method: Seventy‐one participants who met diagnostic criteria for BED based on Eating Disorder Examination (EDE) interview were randomly assigned to DBT‐GSH, DBT‐USH or active control USH for 12 weeks. Assessments took place at baseline, 12 weeks and 3‐month follow‐up. Outcome measures included the EDE to assess binge frequency, the EDE‐Questionnaire (EDE‐Q), the Brief Symptom Inventory, and the Short Form 6D. Results: The overall completion rate was 65% at post‐treatment and 63% at 3‐month follow‐up. Intention to treat analyses showed that participants in all three conditions reported significant reductions in binge frequency with large effect sizes. A similar pattern emerged for secondary outcome variables including eating disorder psychopathology, general psychological distress, and health‐related quality of life. Discussion: Self‐help may be an effective way to disseminate DBT for BED. However, future research should evaluate DBT self‐help using a larger sample size, possibly in a multisite design. [ABSTRACT FROM AUTHOR]

Objectives:T'ai chi (TC) has been found effective for improving chronic low back pain (cLBP). However, such studies did not include adults over 65 years of age. This study was designed to evaluate the feasibility and acceptability of TC in this population compared with Health Education (HE) and with Usual Care (UC). Design: Feasibility randomized controlled trial. Settings/Location: Participants were recruited from Kaiser Permanente Washington and classes took place in a Kaiser facility. Patients: Adults 65 years of age and older with cLBP. Interventions: Twenty-eight participants were randomized to 12 weeks of TC followed by a 24-week tapered TC program, 12 were assigned to a 12-week HE intervention and 17 were assigned to UC only. Outcome Measures: Feasibility and acceptability were determined by recruitment, retention and 12-, 26-, and 52-week follow-up rates, instructor adherence to protocol, class attendance, TC home practice, class satisfaction, and adverse events. Results: Fifty-seven participants were enrolled in two cohorts of 28 and 29 during two 4-month recruitment periods. Questionnaire follow-up completion rates ranged between 88% and 93%. Two major class protocol deviations were noted in TC and none in HE. Sixty-two percent of TC participants versus 50% of HE participants attended at least 70% of the classes during the 12-week initial intervention period. Weekly rates of TC home practice were high among class attendees (median of 4.2 days) at 12 weeks, with fewer people practicing at 26 and 52 weeks. By 52 weeks, 70% of TC participants reported practicing the week before, with a median of 3 days per week and 15 min/session. TC participants rated the helpfulness of their classes significantly higher than did HE participants, but the groups were similarly likely to recommend the classes. Conclusion: The TC intervention is feasible in this population, while the HE group requires modifications in delivery. [ABSTRACT FROM AUTHOR]

Interventions to change children's behavior typically target adults or children, but rarely both. The aims were to: (a) evaluate acceptability and feasibility of an innovative theory-based intervention designed to change both child and adult behavior, and (b) generate effect sizes for a definitive randomized controlled trial. The oral health of sixty children aged 5–9 years with a repaired cleft lip and/or palate was assessed before randomization to one of three conditions: (a) control group, (b) intervention group in which children and adults were asked to form implementation intentions, or (c) intervention plus booster group in which adults were additionally sent a reminder about the implementation intentions they and their children formed. Oral health assessments were repeated at 6-month follow-up alongside exit interviews. The procedures proved popular and participants exposed to the intervention additionally reported believing that forming implementation intentions was effective. Descriptive statistics generally showed oral health improvements across all conditions, although the effects were more marked in the intervention plus booster condition, where plaque improved by 44.53%, gingivitis improved by 20.00% and free sugar consumption improved by 8.92% (vs. 6.43% improvement, 15.00% deterioration and 15.58% improvement in the control group, respectively). Data collection procedures were acceptable and the intervention feasible. The effect sizes suggest that the intervention plus booster condition has sufficient promise to proceed to a fully-powered randomized controlled trial. The intervention has the potential to be adapted to tackle other child health behaviors and to be deployed at scale. [ABSTRACT FROM AUTHOR]

Objective: To explore pregnant women's views of participation in a clinical research trial while pregnant. Design: Prospective nested qualitative cohort study embedded within a national, multi‐site randomized controlled trial of a diagnostic test for preeclampsia: Placental Growth Factor. One‐to‐one in‐depth semi‐structured interviews were undertaken with 19 women who had recently participated in the trial at a single recruiting site. The interviews were conducted in private, recorded digitally and transcribed verbatim. Setting: Single tertiary maternity hospital currently recruiting eligible women onto an on‐going randomized controlled trial (NCT 02881073). Participants: Women who had participated in the PARROT Ireland randomized controlled trial during their recent pregnancy. Methods: Thematic analysis was utilized. Each line of the transcribed interviews was coded into a category by two researchers. The resultant categories were reviewed, and those with similarities were pooled allowing the development of themes. Main Outcome Measures: Women's opinions and experience of participation in a randomized controlled trial of an interventional diagnostic test during their pregnancy. Results: Four major themes were identified as follows: (a) Understanding of preeclampsia, (b) Motivators for clinical trial participation, (c) Barriers to decision making and (d) Influence of PARROT Ireland on pregnancy experience. Conclusions: Women are generally interested and positively inclined to participate in research during pregnancy. The potential of risk is an important consideration for eligible pregnant woman. Information and support by both researchers and clinicians are paramount in aiding women's understanding of a research trial. [ABSTRACT FROM AUTHOR]

An independent, randomized controlled trial of the community-developed, multiple-component Relief Nursery prevention program was conducted with families with young children considered "at risk" for child abuse and neglect. This established program, currently operating at multiple sites in the state of Oregon, comprises an integrated package of prevention services to children and families, including early childhood education, home visiting, and parent education and support, as well as other interventions tailored to the needs of each particular family. Families who contacted the Relief Nursery for the first time were randomly assigned to one of two conditions, the Full Program condition, whose members had access to all services available from the Relief Nursery, or the Respite Care condition, whose members had access only to respite care and referrals to services provided by other community agencies. A primary caregiver in each family was interviewed prior to intervention and then every 6 months across a period of 2 years. Standardized measures were collected on a variety of risk and protective factors related to child abuse and neglect. Analyses were conducted at the end of the study period. Differences were found between the conditions in terms of perceived helpfulness and satisfaction with services and in terms of social support, in each case favoring the Full Program condition. Implications of the findings for future studies of multicomponent child abuse prevention programs with similar characteristics to the Relief Nursery are discussed. [ABSTRACT FROM AUTHOR]

Youth is a period in life when the risk of violence victimization is high and association between victimization and ill health is well established. Youth rarely reveal violence victimization to health professionals if not directly asked but favor health professionals asking about victimization. The study's primary aim was to examine health outcomes in young women being routinely asked about violence victimization and offered subsequent support, compared with controls, at 12-month follow-up. Secondary aims were to examine to what extent routine inquiry altered the consultation and re-victimization rates during the study period. A randomized controlled intervention study was conducted at Swedish youth health centers. Participants assigned to the intervention group were asked structured questions about violence. Victimized participants received empowering strategies and were offered further counseling. Participants in the control group completed questionnaires about victimization after the visit. Both groups answered questions about sociodemographics and health, constructed from validated instruments. A questionnaire was administered to all participants 12 months after baseline. Of 1,445 eligible young women, 1,051 (73%) participated, with 54% of the participants completing the 12-month follow-up. Lifetime violence victimization was reported by 53% in the intervention group and 60% in the control group, ns. There were no significant differences in health outcomes, between baseline and 12-month follow-up, within either group or between groups. Re-victimization rates were 16% in the intervention group and 12% in the control group, ns. Of victimized young women in the intervention group, 14% wanted and received further counseling. Routine inquiry about violence victimization and empowering strategies were feasible within ordinary consultations at youth health centers but did not demonstrate improved health outcomes at 12-month follow-up compared with controls. Questions about violence led to a high degree of disclosure, and 14% of victimized young women in the intervention group received further counseling as a result. [ABSTRACT FROM AUTHOR]

Background: There is a concern that the apparent effectiveness of interventions tested in clinical trials may not be an accurate reflection of their actual effectiveness in usual practice. Pragmatic randomized controlled trials (RCTs) are designed with the intent of addressing this discrepancy. While pragmatic RCTs may increase the relevance of research findings to practice they may also raise new ethical concerns (even while reducing others). To explore this question, we interviewed key stakeholders with the aim of identifying potential ethical challenges in the design and conduct of pragmatic RCTs with a view to developing future guidance on these issues.Methods: Interviews were conducted with clinical investigators, methodologists, patient partners, ethicists, and other knowledge users (e.g., regulators). Interviews covered experiences with pragmatic RCTs, ethical issues relevant to pragmatic RCTs, and perspectives on the appropriate oversight of pragmatic RCTs. Interviews were coded inductively by two coders. Interim and final analyses were presented to the broader team for comment and discussion before the analytic framework was finalized.Results: We conducted 45 interviews between April and September 2018. Interviewees represented a range of disciplines and jurisdictions as well as varying content expertise. Issues of importance in pragmatic RCTs were (1) identification of relevant risks from trial participation and determination of what constitutes minimal risk; (2) determining when alterations to traditional informed consent approaches are appropriate; (3) the distinction between research, quality improvement, and practice; (4) the potential for broader populations to be affected by the trial and what protections they might be owed; (5) the broader range of trial stakeholders in pragmatic RCTs, and determining their roles and responsibilities; and (6) determining what constitutes "usual care" and implications for trial reporting.Conclusions: Our findings suggest both the need to discuss familiar ethical topics in new ways and that there are new ethical issues in pragmatic RCTs that need greater attention. Addressing the highlighted issues and developing guidance will require multidisciplinary input, including patient and community members, within a broader and more comprehensive analysis that extends beyond consent and attends to the identified considerations relating to risk and stakeholder roles and responsibilities. [ABSTRACT FROM AUTHOR]

Background and aims: Smoking cessation medications are effective, but often underutilized because of costs and side effects. Cytisine is a plant‐based smoking cessation medication with more than 50 years of use in central and eastern Europe. While cytisine has been found to be well‐tolerated and more effective than nicotine replacement therapy, direct comparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost‐effectiveness of cytisine compared with varenicline. Design Two‐arm, parallel group, randomized, non‐inferiority trial, with allocation concealment and blinded outcome assessment. Setting: Australian population‐based study. Participants: Adult daily smokers (n = 1266) interested in quitting will be recruited through advertisements and Quitline telephone‐based cessation support services. Intervention and comparator: Eligible participants will be randomized (1 : 1 ratio) to receive either cytisine capsules (25‐day supply) or varenicline tablets (12‐week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10–12‐minute sessions). Measurements Assessments will be undertaken by telephone at baseline, 4 and 7 months post‐randomization. Participants will also be contacted twice (2 and 4 weeks post‐randomization) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self‐reported 6‐month continuous abstinence from smoking, verified by carbon monoxide at 7‐month follow‐up. We will also evaluate the relative safety and cost‐effectiveness of cytisine compared with varenicline. Secondary outcomes will include self‐reported continuous and 7‐day point prevalence abstinence and cigarette consumption at each follow‐up interview. Comments If cytisine is as effective as varenicline, its lower cost and natural plant‐based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives world‐wide. [ABSTRACT FROM AUTHOR]

Abstract Background Postmenopausal Latinas are a growing population group in the US who are at high risk for cardiovascular disease. Epidemiological studies have shown that excessive sitting is related to cardiovascular disease risk. Older women sit for prolonged periods and most individuals do not meet physical activity guidelines. Reducing sitting through increased standing may improve cardiovascular risk. More research is needed on how to intervene to increase standing in older Latinas. Objective To describe the protocol for a randomized controlled trial to increase standing in postmenopausal Latinas: the Arriba por la Vida Estudio (AVE). Design/methods Postmenopausal Latinas will be randomized to one of two study arms: an increase standing intervention or a heart healthy attention-comparison condition. A total of 250 overweight postmenopausal Latinas will be recruited and followed for 12 weeks. AVE is based on various models of behavior change including strategies such as self-monitoring, goal setting, and habit formation. Participants will receive three in-personhealth-counseling sessions (including one in-home visit) and five follow-up telephone calls using motivational interviewing techniques. Those in the attention-comparison condition will receive an equal number of contacts as the standing intervention with topics focused on healthy aging. The primary outcome is objectively-measured sitting time over three months measured via thigh-worn inclinometers and secondary outcomes include blood pressure, physical functioning and glucoregulatory and lipid biomarkers. Conclusions The findings from this study will provide valuable information about effective approaches to increase standing time in postmenopausal Latinas and its impact on cardiovascular disease risk. Trial registration This study is registered at clincialtrials.gov Identifier: NCT02905929 [ABSTRACT FROM AUTHOR]

Objective: This pre-planned secondary analysis of geriatric interdisciplinary home rehabilitation, which was initially found to shorten the postoperative length of stay in hospital for older individuals following hip fracture, investigated whether such rehabilitation reduced the numbers of complications, readmissions, and total days spent in hospital after discharge during a 12-month follow-up period compared with conventional geriatric care and rehabilitation. Design: Randomized controlled trial. Setting: Geriatric department, participants' residential care facilities, and ordinary housing. Subjects: Individuals aged ⩾70 years with acute hip fracture (n = 205) were included. Intervention: Geriatric interdisciplinary home rehabilitation was individually designed and aimed at early discharge with the intention to prevent, detect, and treat complications after discharge. Main measures: Complications, readmissions, and days spent in hospital were registered from patients' digital records and interviews conducted during hospitalization and at 3- and 12-month follow-up visits. Results: No significant difference in outcomes was observed. Between discharge and the 12-month follow-up, among participants in the geriatric interdisciplinary home rehabilitation group (n = 106) and control group (n = 93), 57 (53.8%) and 44 (47.3%) had complications (P = 0.443), 46 (43.4%) and 38 (40.9%) fell (P = 0.828), and 38 (35.8%) and 27 (29.0%) were readmitted to hospital (P = 0.383); the median total days spent in hospital were 11.5 and 11.0 (P = 0.353), respectively. Conclusion: Geriatric interdisciplinary home rehabilitation for older individuals following hip fracture resulted in similar proportions of complications, readmissions, and total days spent in hospital after discharge compared with conventional geriatric care and rehabilitation. [ABSTRACT FROM AUTHOR]

Objective: Continuous subcutaneous insulin infusion (CSII) is on the rise among pediatric patients with type 1 diabetes mellitus. Metabolic effects alone cannot explain this rising popularity. From the patient's perspective, the main benefits of CSII may be found in subjective psychosocial health outcomes (patient‐reported outcomes [PRO]). Subjects and Methods: In a multicenter open randomized controlled trial, children and adolescents aged 6 to16 years currently treated with multiple daily injections (MDI) were randomized 1:1, stratified by center, to either starting with CSII immediately after the baseline interview or to continuing MDI while waiting 6 months for transmission to CSII. The primary outcomes were patient‐reported diabetes‐specific health‐related quality of life (DHRQOL) and diabetes burden of the main caregiver. Secondary outcomes were caregiver stress, fear of hypoglycemia, satisfaction with treatment, and HbA1c. Results: Two‐hundred and eleven patients were randomized between February 2011 and October 2014, and 186 caregivers and 170 patients were analyzed using the intention‐to‐treat principle for primary outcomes. Children 8 to 11 years in the CSII group reported improved DHRQOL at follow‐up compared to MDI (median difference [MD] 9.5, 95% confidence interval [CI] 3.6‐16.7, P = 0.004). There were no treatment differences in the adolescent age‐group 12 to 16 years (MD 2.7; 95% CI −3.2‐9.5; P = 0.353). The main caregivers of the CSII group reported a significant decline of overall diabetes burden at follow‐up compared to the MDI group (MD 0; 95% CI −1‐0; P = 0.029). Secondary PROs also were in favor of CSII. Conclusions: CSII has substantial psychosocial benefits. PROs demonstrate these benefits. Registered as NCT01338922 at clinicaltrials.gov [ABSTRACT FROM AUTHOR]

To evaluate the efficacy of a health-promotion intervention in increasing self-reported physical activity among university students in Sub-Saharan Africa. Randomly selected second-year students at a university in South Africa were randomized to an intervention based on social cognitive theory: health-promotion, targeting physical activity and fruit, vegetable, and fat consumption; or HIV risk-reduction, targeting sexual-risk behaviors. Participants completed assessments via audio computer-assisted self-interviewing pre-intervention and 6 and 12 months post-intervention. A total of 176 were randomized with 171 (97.2%) retained 12 months post-intervention. Generalized-estimating-equations analyses indicated that the health-promotion-intervention participants were more likely to meet physical-activity guidelines than were control participants, post-intervention, adjusting for pre-intervention physical activity (odds ratio [OR] = 3.35; 95% CI: 1.33-8.41). Health-promotion participants reported a greater number of days they did vigorous-intensity (risk ratio [RR] = 2.01; 95% CI: 1.43-2.83) and moderate-intensity (RR = 1.40; 95% CI: 1.01-1.95) aerobic activity, but not strength-building activity (RR = 1.37; 95% CI: 0.091-2.07). The intervention reduced self-reported servings of fried foods (mean difference = −0.31; 95% CI: −0.60, −0.02). The findings suggest that theory-based, contextually appropriate interventions may increase physical activity among university students in Sub-Saharan Africa. [ABSTRACT FROM AUTHOR]

Abstract Background People typically seek primary health care for daytime symptoms and impairments they experience in association with their insomnia. However, few studies address the question of whether insomnia treatment can improve such symptomatology. Objectives To investigate whether a nurse-led group treatment program, based on the techniques of cognitive behavioral therapy for insomnia (CBT-I), improved daytime symptomatology in primary care patients with insomnia. Outcomes Fatigue (Fatigue Severity Scale [FSS]; main outcome), mood (General Health Questionnaire and Montgomery-Asberg Depression Rating Scale), health-related quality of life (Short-Form Health Survey), general daytime functioning, specific daytime symptoms (individual items from the Insomnia Severity Index and Uppsala Sleep Inventory), and dysfunctional beliefs (Dysfunctional Beliefs and Attitudes about Sleep). Design A randomized controlled trial including baseline and post-treatment assessment and a 1-year post-treatment follow-up of the intervention group. Settings Seven primary health care centers (Stockholm, Sweden). Participants One hundred and sixty-five primary care patients who meet the criteria for insomnia disorder (mean age 54 years, SD 16). Most were women (73%). Exclusion criteria: severe untreated illness, bipolar disorder, current stressful life event, night shift work, and untreated sleep disorder other than insomnia. Methods Data came from a randomized controlled trial of a 10-week nurse-led group treatment for insomnia based on CBT-I (n = 90). The control condition was treatment as usual (n = 75). In accordance with intention-to-treat principles, analyses included data on patients who completed baseline assessments (intervention n = 82, and control group n = 71; post-treatment dropout rate 20%). Fifty-four patients were included in the 1-year follow-up. Results Fatigue severity improved significantly more (p < 0.001) in the intervention than in the control group (intervention, total FSS score 37.2 [SD 11.9] to 31.0 [SD 13.4] vs. control 35.9 [SD 12.1] to 35.7 [SD 12.8]). This was true also for measurements on mood (psychological distress and depressive symptoms), health-related quality of life (mental functioning), general daytime functioning, specific daytime symptoms (worry about sleep, sleepiness, bodily tiredness, and difficulty concentrating) and dysfunctional beliefs. All improvements were maintained one year after group treatment. Conclusions Many aspects of the daytime symptomatology of insomnia were improved via nurse-led group treatment based on CBT-I in primary health care. [ABSTRACT FROM AUTHOR]

Compared to cancers at other sites, lung cancer often results in greater psychosocial distress to both the patients and their caregivers, due to the poor prognosis and survival rate, as well as the heavy symptom burden. In recent years, making protocols of proposed or on-going studies publicly available via clinical trial registries and/or peer-reviewed journals has benefited health sciences with timely communication of the latest research trends and improved transparency in reporting. However, such practice is yet to be a common sight in evidence-informed social work. Hence, this paper discusses the value of publishing protocols in social work research and presents the protocol of a randomized controlled trial that compares the effectiveness of integrative body-mind-spirit intervention with cognitive behavioral therapy for enhancing quality of life of patients with lung cancer and their family caregivers. The data collection process was still on-going at the time of manuscript submission. [ABSTRACT FROM AUTHOR]

The health status of toddlers with un-repaired congenital heart disease relies on maternal care behaviors. This randomized control trial investigated the effects of a Dependent Care Support Program on maternal care behaviors. Participants were 50 mothers of toddlers with non-cyanotic congenital heart disease waiting for surgery. They were randomly assigned to either the experimental group (n = 25) or the control group (n = 25). The experimental group received the usual care plus the program. The control group received only the usual care. Data were collected by using the Maternal Care Behaviors for Congenital Heart Disease Toddlers Scale and the Incidence of Illness Recording Form. Data were analyzed using descriptive statistics, Chi-square test, Fisher's exact test, independent t-test, and dependent t-test. Results indicated that the maternal care behaviors in the experimental group at week 6 after program implementation were significantly higher than mothers in the control group and were significantly higher than those before attending the program. The incidence rate of illnesses among children in the experimental group (40%) at week 6 was significantly lower than children in the control group (80%). Nurses may implement the 6-week program to improve maternal care behaviors and their children with congenital heart disease to gain optimum health for surgical treatment as planned. Further study should evaluate the effectiveness of the program in long-term follow-up. [ABSTRACT FROM AUTHOR]

Background and aims There is inconsistent evidence that behavioural support to promote smoking reduction is effective at increasing smoking cessation. We examined the effectiveness of brief physician advice together with four very brief telephone calls in promoting smoking cessation among Chinese men via reduction compared with equivalent advice on diet and exercise. Design A two-group pragmatic randomized controlled trial. Participants and Setting Male patients attending the Endocrinology and Acupuncture out-patient clinics of a general hospital in Beijing, China. Intervention and comparators Physicians advised participants allocated to the smoking-reduction intervention (SRI, n = 181) group to reduce smoking to at least half of their current consumption within 1 month at baseline. At follow-up, a telephone counsellor repeated this advice if the participant had not reduced their cigarette consumption. Participants who had reduced consumption were encouraged to quit smoking. Physicians gave participants in the exercise and diet advice (EDA, n = 188) control group brief advice about physical activity and healthy diet at baseline, and a telephone counsellor reinforced this at each follow-up interview. Both groups had one face-to-face interview at baseline plus five telephone interviews and interventions (approximately 1 minute each) at 1 week and 1-, 3-, 6- and 12-month follow-up. Measurements The primary outcome was self-reported 6-month prolonged abstinence rate at 12-month follow-up interview. Findings By intention-to-treat, the self-reported 6-month prolonged abstinence rate at 12-month follow-up in the SRI groups (19 quitters, 15.7%) was higher, but not significantly, than the EDA control group (10 quitters, 7.8%), and the adjusted odds ratio (OR) and 95% confidence interval (CI) was 2.26 (0.97-5.26), P = 0.062. The self-reported 7-day point prevalence quit rate (secondary outcome) in the SRI group was significantly higher than the control group at each follow-up interview (at 12-month follow-up: 13.3 versus 6.9%, OR (95% CI) = 2.09 (1.01, 4.34), P = 0.049). Conclusions A very brief, proactive and low-cost smoking-reduction intervention without medications for Chinese male smokers with no intention to quit appears to increase smoking abstinence. [ABSTRACT FROM AUTHOR]

Objective: To test the effectiveness of Houvast: a strengths-based intervention for homeless young adults. Method: A cluster randomized controlled trial was conducted with 10 Dutch shelter facilities randomly allocated to an intervention and a control group. Homeless young adults were interviewed when entering the facility and when care ended. Repeated-measures analyses and logistic regression analyses were conducted by the principle of intention-to-treat framework (N = 251). Results: Improvements were demonstrated on quality of life; satisfaction with family relations, finances, and health; employed or in school; depression; care needs; autonomy; competence, and resilience in both conditions. A higher proportion of homeless young adults who received care according to Houvast were still receiving care at follow-up and successfully completed the trajectory compared to those who received care as usual. Conclusion: Homeless young adults seem to benefit from service provision in general. Further research on the effectiveness of Houvast is needed after sufficient model fidelity has been achieved. [ABSTRACT FROM AUTHOR]

Aim: To evaluate the effects of a hospital-community partnership transitional program among patients with coronary heart disease. Methods: This was a randomized controlled trial with 236 patients who were randomized into two groups. The patients in the control group received the usual care. In contrast, the patients in the study group received the transitional care program. The data were collected at the baseline, 30 days, and 90 days after discharge. The primary outcomes were the 30 and 90 day readmission rates after discharge. The secondary outcomes included the quality-of-care transitions, medicine adherence, and chronic disease self-efficacy. Results: The findings indicated that: (i) the patients in the study group reported significantly lower 30 and 90 day readmission rates after their discharge than those in the control group; (ii) statistically significant differences were found in the quality-of-care transitions at 30 days postdischarge between the two groups as the patients in the study group reported significantly higher quality-of-care transitions, compared to those in the control group; and (iii) the patients in the study group reported significantly higher scores in medication adherence and chronic disease self-efficacy at 30 and 90 days after discharge than those in the control group. Conclusion: This study is an original effort to establish and evaluate a hospital-community partnership transitional care program in patients with coronary heart disease in China and the findings have demonstrated its effects. [ABSTRACT FROM AUTHOR]

Background:Assessing the integrity of research climates and sharing such information with research leaders may support research best practices. We report here results of a pilot trial testing the effectiveness of a reporting and feedback intervention using the Survey of Organizational Research Climate (SOuRCe).Methods:We randomized 41 Veterans Health Administration (VA) facilities to a phone-based intervention designed to help research leaders understand their survey results (enhanced arm) or to an intervention in which results were simply distributed to research leaders (basic arm). Primary outcomes were (1) whether leaders took action, (2) whether actions taken were consistent with the feedback received, and (3) whether responses differed by receptivity to quality improvement input.Results:Research leaders from 25 of 42 (59%) VA facilities consented to participate in the study intervention and follow-up, of which 14 were at facilities randomized to the enhanced arm. We completed follow-up interviews with 21 of the 25 leaders (88%), 12 from enhanced arm facilities. While not statistically significant, the proportion of leaders reporting taking some action in response to the feedback was twice as high in the enhanced arm than in the basic arm (67% vs. 33%,p= .20). While also not statistically significant, a higher proportion of actions taken among facilities in the enhanced arm were responsive to the survey results than in the basic arm (42% vs. 22%,p= .64).Conclusions:Enhanced feedback of survey results appears to be a promising intervention that may increase the likelihood of responsive action to improve organizational climates. Due to the small sample size of this pilot study, even large percentage-point differences between study arms are not statistically distinguishable. This hypothesis should be tested in a larger trial. [ABSTRACT FROM PUBLISHER]

Background: Whereas hearing aids have long been considered effective for providing relief from tinnitus, controlled clinical studies evaluating this premise have been very limited. Purpose: The purpose of this study was to systematically determine the relative efficacy of conventional receiver-in-the-canal hearing aids (HA), the same hearing aids with a sound generator (HA+SG), and extended-wear, deep fit hearing aids (EWHA), to provide relief from tinnitus through a randomized controlled trial. Each of these ear-level devices was a product of Phonak, LLC. Research Design: Participants were randomized to HA, HA+SG, or EWHA and wore bilaterally fit devices for about 4 months. Fittings, adjustments, and follow-up appointments were conducted to comply with company guidelines and to ensure that all participants attended appointments on the same schedule. At 4-5 months, participants returned to complete final outcome measures, which concluded their study participation. Study Sample: Participants were 55 individuals (mean age: 63.1 years) with mild to moderately-severe hearing loss who: (a) did not currently use hearing aids; (b) reported tinnitus that was sufficiently bothersome to warrant intervention; and (c) were suitable candidates for each of the study devices. Data Collection and Analysis: The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary outcome measures included hearing-specific questionnaires and the Quick Speech in Noise test (QuickSIN). The goal of the analysis was to evaluate efficacy of the EWHA and HA+SG devices versus the HA standard device. Results: There were 18 participants in each of the HA and EWHA groups and 19 in the HA+SG group. Gender, age, and baseline TFI severity were balanced across treatment groups. Nearly all participants had a reduction in tinnitus symptoms during the study. The average TFI change (improvement) from baseline was 21 points in the HA group, 31 points in the EWHA group, and 33 points in the HA+SG group. A "clinically significant" improvement in reaction to tinnitus (at least 13-point reduction in TFI score) was seen by 67% of HA, 82% of EWHA, and 79% of HA+SG participants. There were no statistically significant differences in the extent to which the devices reduced TFI scores. Likewise, the hearing-specific questionnaires and QuickSIN showed improvements following use of the hearing aids but these improvements did not differ across device groups. Conclusions: There is insufficient evidence to conclude that any of these devices offers greater relief from tinnitus than any other one tested. However, all devices appear to offer some improvement in the functional effects of tinnitus. [ABSTRACT FROM AUTHOR]

Background: unknown elements about clinic environment and negative experiences cause anxiety; and accordingly, they are effective on students’ concentration, memory and problem solving skills, learning/academic success and care given to clinic process Objective: Effect of the clinical preparatory education given to the freshmen nursing students on their anxiety level was to examine. Method: This is an experimental, randomized and a controlled study utilized in a pretest-posttest order. The research was conducted at a health college in Turkey in the period between February, 2014 and March, 2015. The necessary permission was received from the ethical board. By means of simple randomization, whereas 35 students were assigned to the intervention group; 39 students were assigned to the control group. The study data was collected by means of face-to-face interview method in the pre- and post-test periods. In this process, the intervention group was given clinical preparatory education. Data was analyzed in computer environment through statistical software based on mean, percentage, chi-square and t-test. Results: Pre-intervention, nursing students received the intervention and control groups were similar to each other in terms of socio-demographical characteristics and state-trait anxiety starting data (p>0.05). As a result of the intervention, there was no statistically significant difference determined with the intervention group with respect to the control group in terms of state anxiety scores before the clinical experience in the pre-test period. When measurements within each group were taken into consideration, it was determined that state anxiety mean score of the intervention group reduced; and this reduction was statistically significant (p < 0.05).It was observed that there was significant difference among groups in terms of the effect of the clinical preparatory education given before the first clinical experience on the anxiety; but there was significant difference among the measurements within the intervention group itself. [ABSTRACT FROM AUTHOR]

Objectives: The aim was to evaluate an Acceptance commitment therapy (ACT) intervention for people with knee or hip osteoarthritis; a related aim was to compare treatment effects from Rasch-transformed and standard scales. Methods: Participants were recruited from a research database and outpatient rheumatology and orthopaedic clinics at two hospitals. Eligible participants were randomly allocated to either intervention or usual care. Intervention comprised six-sessions of group ACT. Outcomes were assessed two and four months after randomization. Rasch-transformed and standard self-report measures were compared. Qualitative interviews also explored the acceptability of the intervention. Results: Of 87 people assessed for eligibility, 31 (36%) were randomized. The main reason for non-randomization was that participants received surgery. Of the 16 participants randomized to intervention, 64% completed ≥50% of the scheduled group sessions. Follow-up data was complete for 84% participants at two months and 68% at four months. Outcome analysis demonstrated important differences between the Rasch-transformed and standard scales. There were significant differences between the groups in pain. Qualitative interviews with seven participants suggested the intervention was acceptable. Conclusions: ACT for osteoarthritis is likely to be an acceptable treatment option for people with osteoarthritis. Progress to a definitive trial is warranted. Rasch-transformed outcome scales are preferable in clinical trials where possible. Implications for Rehabilitation: Acceptance commitment therapy (ACT) is an effective treatment for many pain conditions andcould be a useful intervention for people with osteoarthritis who have high levels of pain. Rasch analysis is a measurement technique that may enable greater precision in detectingmeaningful treatment effects in routine clinical outcomes. The ACT intervention was successful in reducing pain and sleep difficulties and there werenotable differences in effects between standard and Rasch-transformed scales. In a relatively small trial, ACT may to be an acceptable intervention for people with osteoarthritisand progress to a definitive trial is warranted. [ABSTRACT FROM AUTHOR]

Orphaned and vulnerable children (OVC) experience poverty, stigma, and abuse resulting in poor physical, emotional, and psychological outcomes. The Teachers' Diploma Programme on Psychosocial Care, Support, and Protection is a child-centered 15-month long-distance learning program focused on providing teachers with the knowledge and skills to enhance their school environments, foster psychosocial support, and facilitate school-community relationships. A randomized controlled trial was implemented in 2013–2014. Both teachers (n=325) and students (n=1378) were assessed at baseline and 15-months post-intervention from randomly assigned primary schools in Lusaka and Eastern Provinces, Zambia. Multilevel linear mixed models (MLM) indicate positive significant changes for intervention teachers on outcomes related to self-care, teaching resources, safety, social support, and gender equity. Positive outcomes for intervention students related to future orientation, respect, support, safety, sexual abuse, and bullying. Outcomes support the hypothesis that teachers and students benefit from a program designed to enhance teachers' psychosocial skills and knowledge. [ABSTRACT FROM AUTHOR]

Aim The aim of this study was to evaluate a heart failure education programme developed for patients and carers in Thailand. Background Heart failure is major health problem. This is the first trial of a family-based education programme for heart failure patients and carers residing in rural Thailand. Design Randomized controlled trial. Methods One hundred patient-carer dyads attending cardiac clinics in southern Thailand from April 2014 - March 2015 were randomized to usual care ( n = 50) or a family-based education programme ( n = 50) comprising face-to-face counselling, a heart failure manual and DVD and telephone support. Assessments of heart failure knowledge, health-related quality of life, self-care behaviours and perceived control were conducted at baseline, three and six months. Results Linear mixed-effects model revealed that patients and carers who received the education programme had higher knowledge scores at three and six months than those who received usual care. Among those who received the education programme, when compared with those who received usual care, patients had better self-care maintenance and confidence, and health-related quality of life scores at three and six months, and better self-care management scores at six months, whereas carers had higher perceived control scores at three months. Conclusion Addressing a significant service gap in rural Thailand, this family-based heart failure programme improved patient knowledge, self-care behaviours and health-related quality of life and carer knowledge and perceived control. [ABSTRACT FROM AUTHOR]

Background: Nutrition labeling is a prominent policy to promote healthy eating. Objective: We aimed to evaluate the effects of 2 interpretive nutrition labels compared with a noninterpretive label on consumer food purchases. Design: In this parallel-group randomized controlled trial, we enrolled household shoppers across New Zealand who owned smartphones and were aged ≥18 y. Eligible participants were randomly assigned (1:1:1) to receive either traffic light labels (TLLs), Health Star Rating labels (HSRs), or a control [nutrition information panel (NIP)]. Smartphone technology allowed participants to scan barcodes of packaged foods and to receive allocated labels on their smartphone screens. The primary outcome was the mean healthiness of all packaged food purchases over the 4-wk intervention period, which was measured by using the Food Standards Australia New Zealand Nutrient Profiling Scoring Criterion (NPSC). Results: Between October 2014 and November 2015, 1357 eligible shoppers were randomly assigned to TLL (n = 459), HSR (n = 443), or NIP (n = 455) labels. Overall difference in the mean transformed NPSC score for the TLL group compared with the NIP group was 20.20 (95% CI: 20.94, 0.54; P = 0.60). The corresponding difference for HSR compared with NIP was 20.60 (95% CI: 21.35, 0.15; P = 0.12). In an exploratory per-protocol analysis of participants who used the labeling intervention more often than average (n = 423, 31%), those who were assigned to TLL and HSR had significantly better NPSC scores [TLL compared with NIP: 21.33 (95% CI: 22.63, 20.04; P = 0.04); HSR compared with NIP: 21.70 (95% CI: 22.97, 20.43; P = 0.01)]. Shoppers who were randomly assigned to HSR and TLL also found the labels significantly more useful and easy to understand than the NIP (all P values <0.001). Conclusions: At the relatively low level of use observed in this trial, interpretive nutrition labels had no significant effect on food purchases. However, shoppers who used interpretive labels found them to be significantly more useful and easy to understand, and compared with frequent NIP users, frequent TLL and HSR users had significantly healthier food purchases. This trial was registered at the Australian New Zealand Clinical Trials Registry (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id= 366446&isReview=true) as ACTRN12614000644662. [ABSTRACT FROM AUTHOR]

Objectives:Anxiety in older people is under-diagnosed and poorly treated despite significant impairments that arise from anxiety. Mindfulness-based cognitive therapy (MBCT) has been shown to be a promising treatment for anxiety. The aim of this study was to determine the effect of an MBCT program on anxiety symptoms in older people living in residential care. Method:Fifty-two participants (34 females) were randomly allocated into therapy and control groups using a 2 × 3 mixed design. The average age of participants was 83 years. Results:The group effect showed significant improvements on all measures at the end of the seven-week program in the therapy group, while the control group did not show significant changes. Conclusion:This study represents one of the first studies of the effectiveness of an MBCT program on anxiety symptoms for older people using a randomized controlled trial. The study has implications for future research that include the effectiveness of MBCT for the treatment of anxiety symptoms in older people, the utility of group therapy programs in residential care and the benefits of using specialized instruments for older populations. [ABSTRACT FROM AUTHOR]

The benefit-risk ratio of many interventions remains unclear in older adults with dementia. Efforts for more representative trial inclusion are made; however, recruiting and particularly gaining informed consent remains complex. For research participation, dementia compels the designation of a legal guardian (LG) to give proxy consent. To advance future trial development, we aimed to provide more insights into the factors that affect the proxy decision-making process in dementia research. A qualitative analysis of semi-structured interviews about proxy decision-making on participation in dementia research. LGs of nursing home residents that gave (n = 19) and refrained from giving (n = 18) proxy consent for a clinical trial (the Danton study) in the Netherlands. Verbatim transcripts were thematically analyzed by using a preliminary deductive framework with room for induction of additional emerging themes, being an overall abductive approach. Based on that theme list, related factors of the decision-making process were grouped into overarching levels and merged into a step-by-step process. When discussing proxy decision-making on the participation of an older adult with dementia in a clinical trial, LGs described interconnected factors on the level of the study and patient. Past experiences and attitudes of the LG influenced the weighing of these study- and patient-related factors, leading to a preliminary decision. Other proxies and treating health care professionals (HCPs) were named as important other stakeholders of the decision-making process. When giving proxy consent for research participation, LGs weigh study- and patient-related factors, leading to an initial benefit-risk evaluation. This weighing process is influenced by LG-related factors and can be modulated by other proxies or treating HCPs, leading to a definitive decision. Although insights into these underlying mechanisms could facilitate the proxy decision-making process for both LGs and researchers, treating HCPs could act as an independent party. [ABSTRACT FROM AUTHOR]

Background: Trial participation decisions are often influenced by expectations of potential benefit. Attention has focused on trial participation as a means of securing something seen as desirable, such as experimental treatment. In contrast, we consider a case in which one trial arm involved receiving less than usual care. We explore how this influenced participants’ decisions to participate. Methods: Semi‐structured interviews with 29 women participating in a pilot trial comparing invasive urodynamic testing (typically normal care) to basic clinical assessment with non‐invasive tests, prior to surgical treatment for stress urinary incontinence. Analysis was based on the constant comparative method. Results: Invasive tests were something many were aware of and worried about. Participants understood that trial participation meant they might avoid having these tests, and for about one‐third, this was the primary factor motivating participation. A further third mentioned they were not looking forward to tests (if allocated to them) or were lucky to have missed them (if allocated to basic clinical assessment). None of the women appeared to have discussed their desire to avoid having invasive tests with their clinicians. Conclusions: In contrast to cases in which trial participation is motivated by the wish to secure an intervention not otherwise available, this study reports the opposite – trial participation as an opportunity to avoid having something regarded as undesirable. The option to decline a particular intervention should always be available, and care must be taken to ensure that potential participants are aware that trial participation is not the only possible means of avoidance. [ABSTRACT FROM AUTHOR]